A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
Start Date
10/5/2023
Completion Date
5/1/2027
Summary
This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
LCB84
Anti-PD-1 monoclonal antibody
Conditions
Locations
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Mary Crowley Cancer Research
Dallas, Texas 75230
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada